Estradiol treatment for advanced breast cancer with specific mutations

Phase II Study of Estradiol Therapy to Target ER-Mutant and ER-Wild-Type ER+ Metastatic or Advanced Breast Cancer

This study is testing if a hormone treatment called estradiol can help post-menopausal women with advanced breast cancer that has specific mutations feel better and live longer compared to those without those mutations.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Dartmouth-Hitchcock Medical Center (other)
• Drugs / interventions: Trastuzumab, denosumab
• Locations: 1 site (Lebanon, New Hampshire)
• Trial ID: NCT05716516 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of 17b-estradiol therapy in patients with ESR1-mutant or amplified metastatic breast cancer compared to those with ESR1-wild-type breast cancer. Eligible participants are post-menopausal women with endocrine-resistant breast cancer who have previously received at least one line of endocrine therapy. The treatment phase involves administering estradiol until disease progression, followed by an optional observational phase where patients may receive subsequent treatments at their oncologist's discretion. The study will assess clinical benefits, progression-free survival, and various biomarkers to understand treatment responses better.

Who should consider this trial

Good fit: Ideal candidates are post-menopausal women with ER+ metastatic breast cancer who have previously undergone endocrine therapy.

Not a fit: Patients with known CNS disease, recent history of serious cardiovascular events, or those currently receiving other investigational therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with specific mutations in advanced breast cancer.

How similar studies have performed: Other studies have shown promise in targeting specific mutations in breast cancer, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

* Post-menopausal women with ER+ breast cancer.
* Metastatic or locoregional recurrence not amenable to treatment with curative
* intent.
* Received ≥1 prior line of endocrine-based therapy (e.g., including tamoxifen, aromatase inhibitors, fulvestrant, or combinations) in the advanced/metastatic setting

Exclusion Criteria:

* During the study Treatment Phase with 17b-estradiol, no concurrent anti-cancer therapies are allowed with the following exceptions:

  * Exception: Trastuzumab is allowed for the treatment of subjects with a history of HER2+ disease, and will be used at the physician's discretion.
  * Exception: Anti-resorptive bone therapies (e.g., bisphosphonates, denosumab) are permitted.
* Any investigational cancer therapy in the last 3 weeks.
* Known CNS disease, unless clinically stable for ≥ 3 months.
* History of any of the following:

  * Deep venous thrombosis.
  * Pulmonary embolism.
  * Stroke.
  * Acute myocardial infarction.
  * Congestive heart failure.
  * Previous malignancy not treated with curative intent, or with an estimated recurrence risk ≥30%.

Where this trial is running

Lebanon, New Hampshire

• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States (RECRUITING)

Study contacts

• Principal investigator: Muhammad Azfal, MD — Dartmouth-Hitchcock Medical Center
• Study coordinator: Research Nurse

Conditions: Metastatic Breast Cancer, Metastatic, Locally advanced, Estradiol therapy, Estrogen therapy